Evaluation of the Aurora Xi New Nomogram Software 2.0

Fenwal, Inc.

Status: Completed

Conditions: Apheresis Related Hypotension

Treatments: Device: Aurora Xi New Nomogram Software 2.0; Device: Aurora Xi Currently Approved Software 1.3

Study type: Interventional

Funder types: Industry

Identifiers

NCT06122935

PAND-004-CMD

Details and patient eligibility

About

A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.

Full description

A controlled, prospective, randomized, multicenter, IDE clinical trial to evaluate the safety and effectiveness of a new plasma collection volume nomogram on the Aurora Xi Plasmapheresis System (test arm) as compared to the currently marketed Optimized Nomogram on the Aurora Xi Plasmapheresis System (control arm). The new plasma collection volume nomogram will provide a more individualized approach to determining the volume of plasma collected from each donor. The trial will be conducted at a minimum of 3 plasma collection centers. Subjects will be randomized into the test and control arms.

Enrollment: 52,699 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All subjects must meet current safety guidelines for plasma donation as set forth by the FDA as well as those in the standard operating procedures established by the participating institution.
• Enrolled subjects who do not meet inclusion criteria at a later donation attempt are eligible to remain in the clinical trial and to subsequently donate plasma once they meet eligibility criteria again.

Exclusion criteria

• Subjects not able or unwilling to give consent to participate.
• Subjects withdrawn by a qualified healthcare provider due to safety concerns.
• Subjects who are employed by the clinical site or Sponsor.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52,699 participants in 2 patient groups

Test Group

Experimental group

Description:

Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System

Treatment:

Device: Aurora Xi New Nomogram Software 2.0

Control Group

Active Comparator group

Description:

Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System

Treatment:

Device: Aurora Xi Currently Approved Software 1.3